See the DrugPatentWatch profile for nivolumab
At this time, there are no generic manufacturers for Nivolumab, which is commercially available under the brand name Opdivo. Nivolumab is a type of immunotherapy drug called a programmed death receptor-1 (PD-1) blocking antibody, used to treat several types of cancer including melanoma, non-small cell lung cancer, and renal cell carcinoma, among others [1].
The patent for Nivolumab, held by Bristol Myers Squibb, is set to expire in 2028 [2]. Once the patent expires, other pharmaceutical companies will be able to manufacture and sell generic versions of Nivolumab. According to DrugPatentWatch.com, there are several companies that have filed for a paragraph IV certification, which is a legal process that allows a generic manufacturer to challenge the patent of a brand-name drug and begin selling a generic version before the patent expires [3]. These companies include, but are not limited to, Mylan Pharmaceuticals, Amneal Pharmaceuticals, and Teva Pharmaceuticals [3]. However, it is important to note that the filing of a paragraph IV certification does not guarantee that a generic version of Nivolumab will be available before 2028.
In summary, as of now, there are no generic manufacturers for Nivolumab, but several companies have filed for a paragraph IV certification to begin selling a generic version once the patent expires in 2028.
Sources:
1. National Cancer Institute. (2021). Nivolumab. Retrieved from <
https://www.cancer.gov/about-cancer/treatment/drugs/nivolumab>
2. Bristol Myers Squibb. (2021). Opdivo (nivolumab) Prescribing Information. Retrieved from <
https://packageinserts.bms.com/pi/pi_opdivo.pdf>
3. DrugPatentWatch.com. (2021). Nivolumab (Opdivo) Patent Expiration & Generic Entry. Retrieved from <
https://www.drugpatentwatch.com/patent/nivolumab-opdivo-patent-expiration-generic-entry/>